Extracorporeal Photopheresis (ECP) After Lung Transplantation

Medical University of Vienna

Status

Completed

Conditions

Lung Transplant Rejection

Lung Transplant Infection

Treatments

Device: ECP (Extracorporeal Photopheresis System)

Study type

Interventional

Funder types

Other

Identifiers

NCT05721079

ECP-LUTX V 3.0

Details and patient eligibility

About

The purpose of this study is to investigate the use of ECP for lung-transplanted patients to reduce the occurrence of acute and chronic rejection and CMV-infection.

Full description

The intention of the planned study is the use of ECP as a form of induction treatment in combination with standard triple-drug immunosuppressive therapy (IS). This is a single-center prospective randomized controlled trial conducted at Medical University of Vienna between 2018 and 2020. It includes 31 COPD recipients per group. Treatment group underwent ECP with in addition to IS after lung transplantation. Control group received only IS. The primary outcome was a composite outcome defined as incidence of high-grade ACR, CMV infection or CLAD within 24 months after lung transplantation.

Parallel to the clinical parameters, immunologic investigations will be performed to get a better insight into the mechanisms of ECP on the immune system. The dynamics of Tregs and dentritic cell will be analyzed to compare the influence of ECP vs standard IS.

Enrollment

62 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients undergoing first lung transplantation
Patient underlying disease COPD
Male or female be 18 years or older
Patients (male and female) must agree to use an acceptable method of birth control the treatment period of 3 months and 3 months afterward
Patients must have a body weight more than 40 kg
Patients must have a platelet count more than 20.000/cmm
Patients must be willing and capable of understanding the purpose and risks of the study and must sign a statement of informed consent

Exclusion criteria

Previous organ transplantation
Women who are pregnant and/or lactating
Patients with hypersensitivity or allergy to both heparin and citrate products
Patients who are unable to tolerate extracorporeal volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, renal failure or hepatic failure